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New treatment option for Pancreatic Ductal Adenocarcinoma (PDAC)
Official title Intraperitoneal Paclitaxel With NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis
ClinicalTrials.gov ID: NCT07030283
What this study is testing
What is Paclitaxel?
Paclitaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic ductal adenocarcinoma (pdac).
Also referred to as Taxol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This goal of this clinical trial is to learn whether the drug combination of intraperitoneal paclitaxel (chemotherapy given directly into the abdominal cavity) and intravenous NALIRIFOX (chemotherapy given into a vein, including fluorouracil, leucovorin, oxaliplatin, and liposomal irinotecan) is safe and works in adults with pancreatic cancer that has spread to the peritoneum. The main questions it aims to answer are: Are people with pancreatic cancer able to tolerate the combination drug regimen?
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Be age 18 years or older.
- Histologically or cytologically confirmed pancreatic adenocarcinoma with histologically or cytologically proven seeding in the peritoneal cavity...
- Primary tumor that is resectable, borderline resectable, or locally advanced per NCCN classification.
You likely can't join if
- Prior treatment of pancreatic cancer in the metastatic setting with surgery or investigational therapy (Note: biliary drainage, diagnostic...
- Evident distant metastatic disease outside of the peritoneal cavity.
- Extensive metastatic disease in peritoneal cavity (PCI\>8).
- Known disease progression with any prior chemotherapy.
- Known hypersensitivity to paclitaxel or other liposomal products.
- Current use of strong CYP2C8 inhibitors or inducers, or presence of any other contraindications for paclitaxel.
See the full eligibility criteria
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Be age 18 years or older.
- Histologically or cytologically confirmed pancreatic adenocarcinoma with histologically or cytologically proven seeding in the peritoneal cavity without metastasis to other organs.
- Primary tumor that is resectable, borderline resectable, or locally advanced per NCCN classification.
- PCI score ≤ 8.
- ECOG performance status of 0 or 1
- Prior treatment for 0-4 months with FOLFIRINOX, modified FOLFIRINOX, or NALIRIFOX and able to receive additional treatment per investigator opinion
- Adequate biological parameters as evidenced by all of the following blood counts:
- Absolute neutrophil count (ANC) \>/= 1,500 per cubic millimeter without the use of hematopoietic growth factors within 14 days prior to screening
- Platelet count \>/= 75,000 per cubic millimeter
- Hemoglobin \> 9 g/dL
- Adequate hepatic function as evidenced by:
- Serum total bilirubin ≤ 1.5x ULN (biliary drainage is allowed for biliary obstruction), and
- AST and ALT ≤ 3 x ULN
- Adequate renal function as evidenced by serum creatinine \<1.5 x ULN
- Prior treatment of pancreatic cancer in the metastatic setting with surgery or investigational therapy (Note: biliary drainage, diagnostic laparoscopy/laparotomy, and duodenal stenting is allowed).
- Evident distant metastatic disease outside of the peritoneal cavity.
- Extensive metastatic disease in peritoneal cavity (PCI\>8).
- Known disease progression with any prior chemotherapy.
- Known hypersensitivity to paclitaxel or other liposomal products.
- Current use of strong CYP2C8 inhibitors or inducers, or presence of any other contraindications for paclitaxel.
- Known UGT1A1 deficiency or DPD deficiency.
- Neuropathy Grade 2 or higher
- Known active COVID infection with symptoms.
- Has ever received or is currently receiving radiation for pancreatic cancer treatment.
- Receipt of live, attenuated vaccine within 30 days prior the first dose of Intraperitoneal paclitaxel. (Note: enrolled patients should not receive live vaccines during the study and up to 30 days after the last dose of...
- Known positive test results for human immunodeficiency (HIV) or patients with chronic or active hepatitis B or C. Patients who have a history of hepatitis B or C who have undetectable HBV DNA or HCV RNA after anti-viral...
- Active infection during screening visits or on the day of treatment, which in the investigator's opinion might compromise the patient's participation in the trial or affect the study outcome.
- Any other medical or social condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation...
- Pregnant or breast feeding; females of child-bearing potential must test negative for pregnancy within 7 days prior to C1D1. Both male and female patients of reproductive potential must agree to use a highly effective...
- Histologies other than adenocarcinoma, such as neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.
- Patients who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.